Himplant® Limited Lifetime Defective Product Replacement Warranty Policy
تاريخ السريان: 3 أبريل 2023
This Limited Lifetime Defective Product Replacement Warranty Policy (the "Warranty Policy") is issued by International Medical Devices, Inc. (the "Manufacturer") and applies to the Himplant® medical device.
This Warranty Policy sets forth the sole and exclusive warranty offered by the Manufacturer with respect to the Himplant® device.
1. Warranty Coverage: Defective Products Only
The Manufacturer provides a Limited Lifetime Warranty that applies solely and exclusively to the replacement of a Himplant® device that is determined to be defective in materials or manufacturing.
Sole and Absolute Discretion
The determination of whether a device is defective is made at the sole and absolute discretion of International Medical Devices, Inc.
Express Exclusions
This Warranty Policy does not cover, and expressly excludes, replacement requests arising from surgical or post-surgical complications, adverse clinical outcomes, infection, erosion, migration, pain, dissatisfaction, or cosmetic concerns.
Clinical and Technical Factors
This Warranty Policy further excludes patient-specific anatomical or physiological factors, as well as provider technique, judgment, or post-operative care.
Lifetime Limit
This Warranty Policy allows for one (1) replacement device per patient over the patient’s lifetime. “Lifetime” refers to the lifetime of the patient.
Approval Status
Approval is not automatic and is granted only based on a review of clinical documentation and compliance with the official warranty request process.
2. Reduced Replacement Pricing Schedule
If a warranty request is approved for a defective product, the patient may purchase a replacement device at a reduced price based on the time elapsed from the original implantation:
This Limited Lifetime Defective Product Replacement Warranty Policy (the "Warranty Policy") is issued by International Medical Devices, Inc. (the "Manufacturer") and applies to the Himplant® medical device.
This Warranty Policy sets forth the sole and exclusive warranty offered by the Manufacturer with respect to the Himplant® device.
1. Warranty Coverage: Defective Products Only
The Manufacturer provides a Limited Lifetime Warranty that applies solely and exclusively to the replacement of a Himplant® device that is determined to be defective in materials or manufacturing.
Sole and Absolute Discretion
The determination of whether a device is defective is made at the sole and absolute discretion of International Medical Devices, Inc.
Express Exclusions
This Warranty Policy does not cover, and expressly excludes, replacement requests arising from surgical or post-surgical complications, adverse clinical outcomes, infection, erosion, migration, pain, dissatisfaction, or cosmetic concerns.
Clinical and Technical Factors
This Warranty Policy further excludes patient-specific anatomical or physiological factors, as well as provider technique, judgment, or post-operative care.
Lifetime Limit
This Warranty Policy allows for one (1) replacement device per patient over the patient’s lifetime. “Lifetime” refers to the lifetime of the patient.
Approval Status
Approval is not automatic and is granted only based on a review of clinical documentation and compliance with the official warranty request process.
2. Reduced Replacement Pricing Schedule
If a warranty request is approved for a defective product, the patient may purchase a replacement device at a reduced price based on the time elapsed from the original implantation:
Scope of Discount
This pricing applies solely to the device itself and does not include surgical fees, anesthesia, facility costs, or treatment of complications.
No Reimbursement
This discount is discretionary and does not constitute insurance coverage, reimbursement, or any obligation by the Manufacturer to cover medical costs.
3. Warranty Request and Procedure Requirements
Provider Submission
Warranty requests must be submitted by an active Himplant® provider (listed on the official Himplant® website) using the official Warranty Replacement Request Form.
Review Timeline
A determination will be communicated within seven (7) business days of receipt of a complete submission.
Reporting
Submission requires completion of an adverse event report and all required clinical documentation.
Procedure Timing
Approved replacement procedures must be performed within ninety (90) calendar days of approval.
Reporting Completion
Procedure completion must be reported using the official Himplant® Procedure Tracking Form.
4. Failure to Complete Procedure and Restocking Fees
If an approved replacement procedure is not completed within ninety (90) calendar days of approval:
- The full replacement device price may be billed to the requesting provider
- If the device is returned unused, a $300 restocking fee, plus shipping and handling, will apply
5. Payment and Communication
The patient is solely responsible for payment of the applicable reduced replacement price.
The patient shall remit payment directly to the Himplant® provider.
The Manufacturer does not invoice, collect payment from, or negotiate pricing directly with patients.
6. Device Return and Inspection
If a device is returned, it must be physically intact and show no signs of misuse or alteration.
All returned devices must pass inspection by the Manufacturer’s Quality Assurance Team.
Devices that fail inspection may be billed at the full replacement device price.
No Admission of Defect
Approval of a warranty request is issued for administrative purposes only and does not constitute an admission of defect, failure, or malfunction.
7. Retroactive Application and Supersession
This Warranty Policy supersedes all prior warranty statements, policies, representations, or marketing materials, whether written or oral.
To the maximum extent permitted by applicable law, this Warranty Policy applies to all Himplant® devices implanted before and after the Effective Date.
This Warranty Policy does not limit or exclude any mandatory statutory rights that may apply under local consumer protection laws.
8. Reservation of Rights
The Manufacturer reserves the right to modify, suspend, or discontinue this Warranty Policy at any time, except with respect to warranty requests that have already been approved.
9. Governing Law and Dispute Resolution
This Warranty Policy is governed by the laws of the State of California. Any disputes shall be resolved through binding arbitration in Los Angeles County, California, in accordance with the rules of the American Arbitration Association.
Translations may be provided for convenience. In the event of any inconsistency, the English version shall control.
For warranty questions or submissions, patients must contact an active Himplant® provider listed on the official Himplant® website.